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The acquisition includes one product marketed under an Abbreviated New Drug Application (ANDA) – Ursodiol tablet – and one approved ANDA that is not yet marketed – Lamotrigine

Alectinib’s approval was based on data from a Japanese Phase I/II clinical trial (AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely through

The approval is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In

"We believe these new development initiatives will further increase the value of Celladon’s pipeline and potentially allow us to broaden the clinical utility of MYDICAR for a wide

The marketing authorisation is for a new indication for the use of Arzerra (ofatumumab) in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukaemia (CLL)

The completed acquisition concerns products primarily intended for Asia including Japan, South Korea and Europe excluding some countries. Santen’s payment for the closed transaction totalled about $550m and

The deal aims to broaden patient access to Cimzia and make it available to patients with psoriasis, a chronic autoimmune disorder. Currently, Cimzia is not approved for the

In April 2013, GSK hired Humphrey’s Chinese corporate investigations business, ChinaWhys, to investigate who is behind a suspected smear campaign against the company. In July 2013, Humphrey and

Teva submitted this CP according to the FDA’s procedural guidance and in accordance with the Agency’s desire to facilitate public review and comment regarding new scientific data on